Exact Sciences Corp. (NASDAQ: EXAS), a prominent provider of cancer screening and diagnostic solutions, has announced that the U.S. Food and Drug Administration (FDA) has approved its next-generation multitarget stool DNA test, Cologuard Plus™. This test is now authorized for use in adults aged 45 and older who are at average risk for colorectal cancer (CRC).
The FDA’s approval of the Cologuard Plus™ test was based on the pivotal BLUE-C study, one of the largest head-to-head trials in colorectal cancer (CRC) screening. Among nearly 19,000 average-risk participants, Cologuard Plus demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions, with 94% specificity and no colonoscopy findings. Additionally, the Cologuard Plus test significantly outperformed an independent fecal immunochemical test (FIT) in detecting overall CRC sensitivity, treatable-stage CRC (stages I-III), high-grade dysplasia, and advanced precancerous lesions.
Dr. Thomas F. Imperiale, principal investigator for the BLUE-C study, emphasized the importance of early detection for better outcomes in colorectal cancer, highlighting the Cologuard Plus test’s high sensitivity and specificity, which reduces the risk of false positives, making it a strong option for first-line screening.
Kevin Conroy, Chairman and CEO of Exact Sciences, noted that Cologuard Plus sets a new standard in non-invasive CRC screening, detecting cancers and precancerous polyps with greater sensitivity than the original Cologuard test, while decreasing false positives by over 30%. This advancement is crucial as 60 million Americans are currently behind on their screenings.
Colorectal cancer is often seen as the most preventable yet least prevented cancer, remaining the second deadliest cancer in the U.S. The Cologuard Plus test aims to build on the success of the original Cologuard®, which has been used over 17 million times and has significantly improved national CRC screening rates. Expected to launch in 2025, Cologuard Plus will be supported by Exact Sciences’ commercial team and the ExactNexus™ technology platform, ensuring seamless ordering and results for more than 350 health systems. It is anticipated to receive Medicare coverage and be included in the U.S. Preventive Services Taskforce guidelines.
About the BLUE-C Study
The BLUE-C study (NCT04144738) involved over 20,000 adults aged 40 and older to evaluate the performance of the Cologuard Plus test and an Exact Sciences blood-based CRC screening test. Using colonoscopy as the reference method, the study directly compared Cologuard Plus and an independent FIT. The cohort was diverse, with about 40% identifying as Hispanic, Black, Asian, American Indian, Alaska Native, or Pacific Islander, ensuring the findings are relevant for all eligible individuals.
About the Cologuard Plus Test
Developed with Mayo Clinic, the Cologuard Plus test features novel biomarkers and enhanced laboratory processes, improving sample stability to give patients more time to return their samples, thereby increasing the valid result rate. Exact Sciences is preparing for the test’s commercialization.
